Rep. Elijah Cummings and Sen. Bernie Sanders are turning up the pressure against pharmaceutical giants Teva, Mylan and Heritage Pharmaceuticals as policymakers seek answers on generic drug pricing, FiercePharma reports. Cummings and Sanders, according to the report, allege the companies crafted and […]
Podcast Spotlights RWE in Drug Development
A new podcast in a series titled 'Non-binding Guidance' by Ropes & Gray spotlights the use of real-world evidence in the drug development landscape. Ropes & Gray attorneys Kellie Combs and Sarah Blankstein discuss how the pharmaceutical industry has been utilizing RWE in the development […]
FDA’s OCE, Sypase Partner on RWE
The Food and Drug Administration's Oncology Center of Excellence (OCE) and Syapse are joining forces to bolster the use of real-world evidence to leap over hurdles in trials, Endpoints News reports. The partnership comes as the FDA continues to express its support for RWE in the development […]
Report: Trump Administration Moving Forward with International Pricing Index
The Trump administration is moving forward on a proposal that would implement an international pricing index for some drugs covered under Medicare, The Hill reports. According to the report, Seema Verma, Centers for Medicare and Medicaid Services administrator, called the effort a "top […]
Despite Increasing Interest in RWE, Barriers Remain
While regulators have expressed interest in facilitating real-world evidence (RWE) in the drug development pipeline, a number of key obstacles, such as infrastructure and data concerns, remain, according to a PMLiVE report. Drugmaker Pfizer recently was able to lean on data from electronic health […]
ICER: Zolgensma Review Not Compromised by Data Issue
The Institute for Clinical and Economic Review (ICER) on Wednesday, Aug. 7, said recent issues with animal testing data for Novartis' Zolgensma will not require an updated review of the initial assessment. The drug pricing watchdog's statement comes on the heels of the Food and Drug […]
Analyst: Congress Likely to Pass Drug Pricing Bill Ahead of 2020 Election
RBC Capital Markets in a note to investors this week suggested Congress could pass a drug pricing bill in a bid to post a policy "win" ahead of the 2020 elections, according to a CNBC report. "Dynamics into election look to be [a] perfect storm," RBC analyst Brian Abrahams said in the note. "While […]
Trump Announces Plan to Allow Prescription Drugs from Canada
The Trump administration on Wednesday announced new a new plan to facilitate the importation of lower-cost prescription drugs from Canada, the Associated Press reports. According to the report, it's unclear when consumers could expect to benefit from such a proposal, as well as how Canada might […]
Webinar Spotlights Legislative Outlook for CER
A recent webinar hosted by the Alliance for Health Policy looks at what could be in store for comparative effectiveness research in the legislative arena. The webinar was posted on YouTube July 29. "This webinar outlined the various PCORI reauthorization bills and amendments that have been […]
NPC’s Leonard Highlights New Approaches to Finance Innovative Therapies
States are adopting creative solutions to improve how taxpayer dollars are being spent to meet the health care needs of their patients, Dan Leonard, president and CEO of the National Pharmaceutical Council, writes in a recent column on Specialty Pharmacy Times. Louisiana, he writes, is one example […]
Blog Post: Pressure to Cut Drug Prices to Persist
Despite President Donald Trump's White House having scrapped a plan that would have eliminated rebates for some drugs under Medicare, pressure to find solutions to high prices will remain, a recent Deloitte blog post suggests. The pharmaceutical industry, the author writes, should also take steps […]
Cummings Announces Plans to Get Pharma Execs to Testify on Drug Prices
Following a Friday hearing on drug prices and their impact on patients, Rep. Elijah Cummings, House Oversight and Reform Committee chairman, announced plans for a hearing in which pharmaceutical executives would be called to testify on prices, The Hill reports. "I want to tell you, this may make […]
Grassley Touts Drug Pricing Bill
Republican Sen. Chuck Grassley on Thursday sought support for his key drug pricing proposal, saying that his plan would outmatch anything produced by President Donald Trump and Democrats, STAT reports. "Who knows what he's going to do at the last minute," Grassley, chairman of the Senate Finance […]
Senate Committee Green Lights Drug Pricing Bill
With unanimous support from Democrats, a Senate committee on Thursday cleared a key drug pricing bill which includes a cap on some price hikes under Medicare, STAT reports. The package was pushed through with a 19-9 vote. Five Republicans voted against the bill. To read the full report on STAT, […]
NICE to Review Guidance Development Protocol
The U.K.'s National Institute for Health and Care Excellence (NICE) is planning to review how it develops guidance on prescription drugs, pharmaphorum reports. According to the report, NICE will cover a number of topics as part of its review, including uncertainty in evidence. "NICE is undertaking […]
Report: NHS Patient Data Could be Worth Billions
A new report from Ernst and Young suggests the U.K.'s National Health Service's (NHS) patient records could be worth billions of British pounds, pharmaphorum reports. According to the pharmaphorum report, NHS has records on some 55 million patients. "The quality and scale of NHS data, covering a […]
How Does Pharma Stay Strong in Washington?
A recent report by STAT looks at how the pharmaceutical industry, despite being the target of attacks from all sides, continues to keep its grip in Washington. To read the report, click here. (Paid subscription required) […]
Report Highlights Convoluted Drug Pricing Pipeline
While Health and Human Services (HHS) Secretary Alex Azar in a speech last year compared drug list prices to sticker prices for cars, experts tell NPR that analogy doesn't really hold up. The situation could be life or death when it comes to drug prices. "You're not going to die if you don't have […]
eyeforpharma Webinar to Talk Impact of RWE on RCTs
Real-world evidence (RWE) and how it could impact randomized clinical trials (RCTs) will take center stage during an upcoming webinar being offered by eyeforpharma. The webinar is set to begin 9:30 a.m. EST Tuesday, July 23. Panelists include: Sebastian Schneeweiss, professor of medicine and […]
Slow Momentum on Drug Pricing Reform Frustrates Some
Some advocacy groups are expressing their frustrations at the seemingly slow pace at which U.S. policymakers are moving on drug pricing reform, The Hill reports. Julie Allen, senior vice president of the District Policy Group at Drinker Biddle, tells The Hill their expectations for the remainder of […]
Industry, FDA: RWE Needs Standardized Definition in Clinical Trials
The Food and Drug Administration (FDA) and pharmaceutical industry agree real-world evidence (RWE) and real-world data (RWD) both need standardized definitions as their use in clinical trials grows, CenterWatch reports. The FDA's Robert Temple during a recent workshop said there is "tremendous […]
Germany Agency Calls for Drug Development, Approval Reforms
The Institute for Quality and Efficiency in Health Care (IQWiG) is calling for international reforms to the drug development and approval cycles, FiercePharma reports. According to the report, the agency found that only 25 percent (54) of 216 approvals between 2011 and 2017 delivered major health […]
FDA’s Woodcock Talks Big Changes
Janet Woodcock, chief of the FDA's Center for Drug Evaluation and Research, recently discussed a host of key changes being made at the agency, according to an Endpoint News report. According to the report, Woodcock touched on changes to clinical trial designs and other aspects of drug […]
Trump Scraps Rebate Proposal
The Trump administration this week scrapped a key proposal that would have eliminated pharma-PBM rebates in Medicare, an effort aimed at reducing prescription drug prices, the Washington Post reports. According to the report, the the administration's decision to pull the plug on the proposal […]
More on ACA Hearing
A federal court heard arguments on the constitutionality of the Affordable Care Act health care mandate this week. To read about the 90-minute hearing, click here to read Fierce Healthcare's report. […]
Uncertainty Abound on ACA Mandate
The fate of the Affordable Care Act's health care mandate remains uncertain after a hearing Tuesday in which a panel of federal appeals court judges listened to oral arguments on the rule's constitutionality, the New York Times reports. It remains unclear, according to the report, what scrapping […]
Judge Blocks Trump’s Rule on Drug Prices in DTC Ads
A federal judge this week blocked the Trump administration's rule requiring pharmaceutical companies include a drug's list price in television ads, STAT reports. The decision argues Health and Human Services (HHS) had insufficient authority to force drugmakers to disclose list prices in TV ads, and […]
Hearing Today on ACA’s Constitutionality
A hearing today, July 9, at the 5th Circuit Court of Appeals in New Orleans could decide whether a federal judge's ruling that the Affordable Care Act is unconstitutional will stick. According to a Kaiser Health News report, the hearing is poised for the Supreme Court, and could play a key role in […]
Report: Widespread Inaccuracies in Medicare Advantage Plan Directories
A Centers for Medicare and Medicaid Services (CMS) audit and other researchers have found widespread inaccuracies in Medicare Advantage plan directories, according to a recent article by Austin Frakt published on the New York Times. According to the article, CMS, which oversees the […]
Trump Vows Executive Action on Drug Prices
As part of his plan to reduce drug prices, President Donald Trump last week announced his administration would issue an executive order that he said would cap the U.S.'s payments for drugs, STAT reports. "Why should other nations — like Canada — but why should other nations pay much less than us?" […]
